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Compliance Services

Human Subjects

View All ORC Announcements


New IRB Procedure for Study Closure Released April 27, 2017

The Human Subjects Office has released new procedures for study closure. As of April 27, 2017, the previously-used Study Closure Report form will no longer be accepted, and study closure should be reported via KC IRB. (more...)

Updated IRB Processes and Procedures Released February 23, 2017

The Human Subjects Office (HSO) has released several updates to IRB processes and procedures, including enhancements to KC IRB. The release includes a new submission process for reportable events as well as the consequent retirement of two related IRB forms, publication of three new guidance documents for investigators, revisions to several KC IRB questionnaires, and revisions to the IU Standard Operating Procedures for Research with Human Subjects (IU SOPs). (more...)

Welcome to the Human Subjects Office

The IU Human Subjects Office is the administrative office that supports the Indiana University Institutional Review Boards (IRBs), which are responsible for the review and approval of all research involving human subjects conducted at IU and its affiliated institutions. The HSO administers the human research protection program (HRPP) at IU. IU’s HRPP, which will include the regional campuses effective July 1, 2015, is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

The HSO includes about 30 staff members who support more than 5,000 active human subjects studies, seven IRBs, and the IRB Executive Committee comprised of Chairs and Vice Chairs of each IRB. HSO staff are experts in human subjects protections, and several have achieved the Certified IRB Professional certification. Staff are divided into four teams, based on level of review and type of research. Team listings are available in HSO Support Teams or you may search our Staff Directory for a specific person.

Please see the links below for more information on how to conduct human subjects research at Indiana University (or an affiliated institution).

Lifecycle Basic Steps

1. Level of review

How to decide if your study needs review and how it should be submitted to the IRB

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2. Getting started

Information and preparation needed prior to submitting to the IRB

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3. Submission

How to submit a study to the IRB

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4. Review

What does the IRB do, and how does the process work?

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5. Post-Approval

What happens after my study is approved?

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Information for Sponsors Information for Subjects